What is the primary objective of **REACH**?

**The primary objective of REACH is to ensure a high level of protection for human health and the environment from chemical risks while enhancing EU industry competitiveness and promoting alternative testing methods.** Under **Regulation (EC) No 1907/2006**, it shifts responsibility to industry for registering substances, generating hazard and exposure data, and implementing risk management via its four pillars: **Registration**, **Evaluation**, **Authorisation**, and **Restriction**.

Who is legally or professionally required to comply with **REACH**?

**REACH legally requires manufacturers, importers, and downstream users in the EU/EEA to comply when manufacturing or importing substances exceeding 1 tonne per year per legal entity.** This includes substances in mixtures and, for articles, SVHC notification if ≥0.1% w/w and >1 tonne/year total. Non-EU entities appoint an **Only Representative**; obligations cover SDS provision, exposure scenarios, and Article 33 consumer responses within 45 days.

Does **REACH** require an external audit or third-party certification?

**No, REACH does not require external audits or third-party certification.** It is a directly applicable regulation enforced by Member State authorities via inspections, with ECHA coordinating dossier evaluations. Compliance is demonstrated through maintained registration dossiers, 10-year recordkeeping, and inspection readiness; no "REACH certificates" are issued.

How often should an assessment for **REACH** be performed?

**REACH assessments must be performed continuously as a living compliance obligation, with updates triggered by events like tonnage changes, new hazards, Candidate List additions, or Annex XIV/XVII amendments.** Annual tonnage reviews and monitoring of ECHA's CoRAP, SVHC Roadmap (250+ entries as of 2025), and restriction updates ensure dossiers remain current; SDS updates occur "without delay."

What are the consequences of non-compliance with **REACH**?

**Non-compliance with REACH results in penalties that are effective, proportionate, and dissuasive, enforced by Member State authorities.** These include administrative fines, product seizures, market withdrawal, and potential criminal sanctions; coordinated via ECHA's Forum. Variability exists across states, but risks encompass market exclusion and supply-chain disruptions from unregistered substances or missed SVHC notifications.

Can **REACH** be mapped to other international frameworks?

**Yes, REACH can be mapped to other international frameworks, though it stands as an independent EU regulation.** Its data requirements, hazard assessments, and risk management align with global systems like GHS for SDS, OECD for testing, and certain national chemicals laws, facilitating data reuse and mutual recognition where confidentiality allows.

What is the first step to begin implementing **REACH**?

**The first step to implement REACH is to conduct a gap analysis by building a master substance inventory with tonnage per legal entity.** Identify substances >1 tonne/year, map to roles (manufacturer/importer/downstream user), prioritize by hazard and Annex lists, and establish cross-functional governance for registration and supply-chain communication.

What is the primary objective of **ISO 22000**?

**ISO 22000 enables organizations to consistently provide safe products through a Food Safety Management System (FSMS) that prevents, eliminates, or reduces food safety hazards to acceptable levels.** It integrates **PRPs**, **hazard analysis**, **CCPs/OPRPs**, and management system requirements across Clauses 4–10 using **two nested PDCA cycles** (organizational and operational). The standard ensures compliance with statutory/regulatory and customer requirements via effective internal/external communication, providing a basis for certification.

Who is legally or professionally required to comply with **ISO 22000**?

**No organization is legally required to comply with ISO 22000, as it is a voluntary international standard.** It applies professionally to any entity in the food chain—**directly or indirectly**—including primary producers, feed/animal food producers, processors, packaging manufacturers, transport/storage providers, retailers, food services, and supporting suppliers. Certification demonstrates FSMS assurance to customers, regulators, and markets.

Does **ISO 22000** require an external audit or third-party certification?

**ISO 22000 requires internal audits (Clause 9.2) but external audits and third-party certification are voluntary.** Certification by accredited bodies follows a two-stage process: Stage 1 (readiness) and Stage 2 (implementation), with annual surveillance and triennial recertification. It confirms FSMS conformity across all clauses, including **PRPs**, **hazard control plans**, and **management reviews**.

How often should an assessment for **ISO 22000** be performed?

**Internal audits for ISO 22000 must be conducted at planned intervals, typically risk-based with high-risk processes audited more frequently.** **Management reviews** occur at predetermined intervals (e.g., annually or semi-annually), incorporating performance data, audit results, and context changes (Clause 9.3). Continual assessments via monitoring, verification, and corrective actions (Clauses 9–10) ensure ongoing FSMS effectiveness.

What are the consequences of non-compliance with **ISO 22000**?

**Non-compliance with ISO 22000 results in certification denial, suspension, or withdrawal by the certification body.** Internally, it leads to ineffective hazard control, potential food safety incidents, recalls, regulatory penalties under applicable laws, supply chain exclusion, and brand damage. No direct fines from ISO, but failure exposes organizations to statutory enforcement and market loss.

Can **ISO 22000** be mapped to other international frameworks?

**Yes, ISO 22000:2018 adopts the High-Level Structure (HLS/Annex SL), enabling seamless mapping and integration with ISO management system standards.** Its PDCA cycles, risk-based planning (Clause 6), and Clause 4–10 structure align with other ISO standards, supporting combined audits and integrated systems while embedding food safety-specific requirements like **hazard analysis** and **OPRPs/CCPs**.

What is the first step to begin implementing **ISO 22000**?

**The first step is determining the FSMS scope, organizational context, and interested parties' requirements (Clause 4).** Conduct a gap analysis against ISO 22000:2018 clauses, appoint leadership and a food safety team, and establish a food safety policy (Clause 5) to drive risk-based planning.

REACH vs ISO 22000

Standards Comparison

REACH

Mandatory

2007

EU regulation for chemical registration, evaluation, authorisation, restriction

ISO 22000

Voluntary

2018

International standard for food safety management systems

Quick Verdict

REACH mandates chemical safety registration and restrictions for EU manufacturers/importers, ensuring hazard control. ISO 22000 provides voluntary FSMS certification for food chain organizations worldwide, integrating HACCP for hazard prevention. Companies adopt REACH for legal compliance, ISO 22000 for market trust.

Chemical Safety

REACH

Regulation (EC) No 1907/2006 (REACH)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Shifts burden of proof to industry for chemical risks
Registration required for substances over 1 tonne/year
Authorisation regime drives SVHC substitution
Annex XVII imposes EU-wide use restrictions
Mandates SVHC communication down supply chain

Food Safety

ISO 22000

ISO 22000:2018 Food safety management systems

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

High-Level Structure for integrated management systems
Dual PDCA cycles for strategic and operational control
Hazard analysis with CCPs and OPRPs categorization
Prerequisite programs establishing hygiene baseline
Interactive communication across food chain

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

REACH Details

What It Is

REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation managing chemical risks across the lifecycle. It shifts responsibility to industry for registration, evaluation, authorisation, and restriction of substances, mixtures, and articles, ensuring high protection for health and environment via risk-based data generation.

Key Components

Four pillars: Registration (>1 tonne/year dossiers), Evaluation (dossier/substance checks), Authorisation (Annex XIV SVHC permissions), Restriction (Annex XVII bans/limits).
17 technical annexes define data requirements, SDS rules, exemptions.
Built on precautionary principle; no certification, but continuous compliance with ECHA oversight.

Why Organizations Use It

Legal mandate for EU market access; non-compliance risks fines, seizures, market bans.
Enhances supply-chain transparency, reduces risks, drives substitution for competitiveness.
Builds stakeholder trust via SVHC communication (Article 33), supports ESG goals.

Implementation Overview

Phased: gap analysis, substance inventory, dossiers via IUCLID, SDS management, monitoring.
Applies to manufacturers/importers/downstream users in chemicals, manufacturing sectors EU-wide.
No certification; requires audits, 10-year records, event-driven updates. (178 words)

ISO 22000 Details

What It Is

ISO 22000:2018 is the international standard for Food Safety Management Systems (FSMS). It provides a certifiable framework for organizations in the food chain to ensure safe products through systematic hazard control. Its risk-based approach integrates HACCP principles with management system discipline using the High-Level Structure (HLS).

Key Components

**Clauses 4-10Context, leadership, planning, support, operation, evaluation, improvement.
**Core elementsPrerequisite programs (PRPs), hazard analysis, CCPs/OPRPs, traceability, communication.
Built on Codex HACCP and dual PDCA cycles (organizational and operational).
Voluntary certification via accredited bodies.

Why Organizations Use It

Meets regulatory/customer requirements; enables market access.
Reduces risks of recalls, contamination; builds stakeholder trust.
Drives efficiency, integration with ISO 9001/14001; enhances reputation.

Implementation Overview

Phased: gap analysis, PRPs, hazard control plan, training, audits.
Applies to all food chain actors, scalable by size.
Requires internal audits, management reviews; certification every 3 years. (178 words)

Key Differences

Aspect	REACH	ISO 22000
Scope	Chemicals registration, evaluation, authorisation, restriction	Food safety management systems with HACCP integration
Industry	Chemicals, manufacturing, import/export across EU/EEA	All food chain organizations globally (producers to retail)
Nature	Mandatory EU regulation directly applicable	Voluntary international certification standard
Testing	Dossier submission, substance evaluation by ECHA	Internal audits, management reviews, certification audits
Penalties	National fines, product seizures, market bans	Loss of certification, no direct legal penalties

Scope

REACH

Chemicals registration, evaluation, authorisation, restriction

ISO 22000

Food safety management systems with HACCP integration

Industry

REACH

Chemicals, manufacturing, import/export across EU/EEA

ISO 22000

All food chain organizations globally (producers to retail)

Nature

REACH

Mandatory EU regulation directly applicable

ISO 22000

Voluntary international certification standard

Testing

REACH

Dossier submission, substance evaluation by ECHA

ISO 22000

Internal audits, management reviews, certification audits

Penalties

REACH

National fines, product seizures, market bans

ISO 22000

Loss of certification, no direct legal penalties

Frequently Asked Questions

Common questions about REACH and ISO 22000

REACH FAQ

ISO 22000 FAQ

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REACH

ISO 22000

Quick Verdict

REACH

Key Features

ISO 22000

Key Features

Detailed Analysis

REACH Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 22000 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

REACH FAQ

What is the primary objective of REACH?

Who is legally or professionally required to comply with REACH?

Does REACH require an external audit or third-party certification?

How often should an assessment for REACH be performed?

What are the consequences of non-compliance with REACH?

Can REACH be mapped to other international frameworks?

What is the first step to begin implementing REACH?

ISO 22000 FAQ

What is the primary objective of ISO 22000?

Who is legally or professionally required to comply with ISO 22000?

Does ISO 22000 require an external audit or third-party certification?

How often should an assessment for ISO 22000 be performed?

What are the consequences of non-compliance with ISO 22000?

Can ISO 22000 be mapped to other international frameworks?

What is the first step to begin implementing ISO 22000?

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Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

APPI vs ISO/IEC 42001:2023

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CSL (Cyber Security Law of China) vs COBIT